NCT00180310

SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System

A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System. TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.

Detailed description

The SPIRIT II trial was a randomized, single blind, active control, multi-center clinical evaluation. Subject eligibility criteria were similar to SPIRIT III and enrollment duration overlapped between studies. In this study, 300 subjects (3:1 randomization XIENCE V® EECSS: TAXUS™ PECSS were enrolled at 31 sites outside the United States. The primary endpoint was in-stent late loss at 6 months. Secondary endpoints included clinical outcomes at months 1, 6, and 9 months and 1, 2, 3, 4 and 5 years; angiographic results at 6 months and 2 years; and IVUS results at 6 months and 2 years. Follow-up through 3 years is currently available.

Conditions

• Coronary Disease
• Coronary Artery Disease
• Coronary Restenosis

Interventions

Type	Name	Description
DEVICE	XIENCE V® Everolimus Eluting Coronary Stent	Drug eluting stent implantation stent in the treatment of coronary artery disease.
DEVICE	TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent	Drug eluting stent implantation stent in the treatment of coronary artery disease

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-07-01
• Completion: 2011-02-01
• First posted: 2005-09-16
• Last updated: 2011-07-20

Locations

32 sites across 13 countries: Austria, Belgium, Denmark, France, Germany, India, Italy, Netherlands, New Zealand, Poland, South Africa, Spain, Switzerland